Efficacy of Pharmacokinetics-Directed Busulfan, Cyclophosphamide, and Etoposide Conditioning and Autologous Stem Cell Transplantation for Lymphoma: Comparison.

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Presentation transcript:

Efficacy of Pharmacokinetics-Directed Busulfan, Cyclophosphamide, and Etoposide Conditioning and Autologous Stem Cell Transplantation for Lymphoma: Comparison of a Multicenter Phase II Study and CIBMTR Outcomes Christopher R. Flowers, Luciano J. Costa, Marcelo C. Pasquini, Jennifer Le-Rademacher, Michael Lill, Tsiporah B. Shore, William Vaughan, Michael Craig, Cesar O. Freytes, Thomas C. Shea, Mitchell E. Horwitz, Joseph W. Fay, Shin Mineishi, Damiano Rondelli, James Mason, Ira Braunschweig, Weiyun Ai, Rosa F. Yeh, Tulio E. Rodriguez, Ian Flinn, Terrance Comeau, Andrew M. Yeager, Michael A. Pulsipher, Isabelle Bence-Bruckler, Pierre Laneuville, Philip Bierman, Andy I. Chen, Kazunobu Kato, Yanlin Wang, Cong Xu, Angela J. Smith, Edmund K. Waller Biology of Blood and Marrow Transplantation Volume 22, Issue 7, Pages 1197-1205 (July 2016) DOI: 10.1016/j.bbmt.2016.03.018 Copyright © 2016 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 1 Measured AUC from .8 mg/kg of i.v. Bu as a preconditioning test PK on of the days, day −14 to day −11 (n = 204). Dotted line represents ± 20% range of the target AUC (1000-1500 μM·min). Biology of Blood and Marrow Transplantation 2016 22, 1197-1205DOI: (10.1016/j.bbmt.2016.03.018) Copyright © 2016 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 2 Histograms of estimated total AUC from test PK and confirmatory PK results (n = 199). Dotted line represents the ± 20% range of the target AUC (16,000-24,000 μM·min). Biology of Blood and Marrow Transplantation 2016 22, 1197-1205DOI: (10.1016/j.bbmt.2016.03.018) Copyright © 2016 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 3 Scatter plot of total estimated Bu AUC for all patients and of actual Bu AUC for patients with AEs of TRM and mucositis/stomatitis (M/S). Scatter plots represent subjects with no M/S and grades (GR) 1, 2, and 3 M/S. There were no cases of GR 4 M/S. Biology of Blood and Marrow Transplantation 2016 22, 1197-1205DOI: (10.1016/j.bbmt.2016.03.018) Copyright © 2016 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 4 OS for the phase II study of PK-directed BuCyE conditioning and ASCT for lymphoma. (A) HL/NHL. (B) NHL subtypes. Biology of Blood and Marrow Transplantation 2016 22, 1197-1205DOI: (10.1016/j.bbmt.2016.03.018) Copyright © 2016 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 5 PFS for the phase II study of PK-directed BuCyE conditioning and ASCT for lymphoma. (A) HL/NHL. (B) NHL subtypes. Biology of Blood and Marrow Transplantation 2016 22, 1197-1205DOI: (10.1016/j.bbmt.2016.03.018) Copyright © 2016 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 6 Comparison of survival for NHL patients in the matched analysis of phase II BuCyE and contemporary lymphoma patients treated with BEAM from CIBMTR. (A) OS. (B) PFS. Biology of Blood and Marrow Transplantation 2016 22, 1197-1205DOI: (10.1016/j.bbmt.2016.03.018) Copyright © 2016 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 7 Comparison of survival for HL patients in the matched analysis of phase II BuCyE and contemporary lymphoma patients treated with BEAM from CIBMTR. (A) OS. (B) PFS. Biology of Blood and Marrow Transplantation 2016 22, 1197-1205DOI: (10.1016/j.bbmt.2016.03.018) Copyright © 2016 American Society for Blood and Marrow Transplantation Terms and Conditions